Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-077-8 | CAS number: 91-56-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute toxicity: via oral route: Key study: Test method according to OECD Guideline 420. GLP study. No mortality was observed following single administration of the test item at a dose of 2000 mg/kg bw in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 March 2015 - 31 March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD Guideline 420. GLP study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Medicine Centre at the Medical University in Białystok
- Age at study initiation: 11 weeks old
- Weight at study initiation: 207.3 g
- Fasting period before study:
- Housing: plastic cages covered with wi re bar lids. The dimensions of the cages were 58 x 37 x 21 cm (length x width x height).
- Diet (e.g. ad libitum): “Murigran” standard granulated laboratory fodder, ad libitum.
- Water (e.g. ad libitum): drinking tap water, ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 – 23 °C
- Humidity (%): 40 – 58%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle (if gavage): 1 mL
MAXIMUM DOSE VOLUME APPLIED: 0.5 mL/100 g b.w.
- Rationale for the selection of the starting dose: The starting dose for the preliminary experiment was selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg b.w. as a dose expected to produce evident toxicity. Since no data were available, the preliminary experiment started with the administration of the test item at a dose of 300 mg/kg b.w to one female rat. Since no evident toxicity was produced, the test item at a single dose of 2000 mg/kg b.w. was administered to the second animal. The animal treated with the test item at a dose of 2000 mg/kg b.w. survived the experiment. On the grounds of the preliminary experiment results, the dose of 2000 mg/kg b.w. was selected to be used in the main experiment. - Doses:
- Sighting study: 300 and 2000 mg/kg b.w.
Main study: 2000 mg/kg b.w. - No. of animals per sex per dose:
- 2 females in the sighting study.
4+1 (from the preliminary study) females in the main study. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: body weights were determined on days 0 (directly before the administration of the test item), 7, and 14 (before euthanasia).
- Necropsy of survivors performed: yes.
- Other examinations performed:
General condition: the observation of all animals for morbidity and mortality was conducted twice a day or once a day (on days off) during the 14-day experiment.
Detailed clinical observations: the detailed clinical observations were performed on the day of the test item administration (day 0), i.e. 10, 30, and 60 minutes after the administration and then at hourly intervals up to the 5th hour after the administration. From the 1st to the 14th day of the experiment, the detailed clinical observations were performed once a day.
Gross examinations: After the 14-day observation period, all animals were euthanized by intraperitoneal administration of Morbital at a dose of 200 mg/kg b.w. and subjected to gross examinations. The detailed gross examinations involved the observation of the external body surface, all natural apertures, and the cranial, thoracic, and abdominal cavities with their content. - Preliminary study:
- Following single administration of the test item at a dose of 300 mg/kg b.w. to the first animal used in the preliminary experiment, no signs of toxicity were stated. The animal survived the experiment.
Following single administration of the test item at a dose of 2000 mg/kg b.w. to the other animal used in the preliminary experiment, the rounded back, slightly decreased locomotor activity, and dejection were stated on the administration day. The animal survived the experiment. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the experiment.
- Clinical signs:
- other: The rounded back, slightly decreased locomotor activity, and dejection were stated in all animals on the administration day.
- Gross pathology:
- The animals did not exhibit any pathological changes.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality was observed following single administration of the test item at a dose of 2000 mg/kg bw in rats. The test substance is not classified according to the CLP Regulation (EC) no 1272/2008.
- Executive summary:
The acute oral toxicity study on Wistar rats was performed according to the OECD Guideline 420 and EU Method B.1. bis, following the Principles of GLP. The test item was prepared as an oil suspension in a volume of 0.5 mL/100 b.w. and it was administered with a metal stomach tube. A preliminary experiment started with the administration of 300 mg/kg b.w. of the test item to one animal. Since no evident toxicity was observed, a second animal was dosed at 2000 mg/kg b.w. The animal survived the experiment but presented signs of toxicity: rounded back, slightly decreased locomotor activity, and dejection were stated on the administration day.
In the main experiment 4 animals received 2000 mg/kg b.w of the test item. After the administration of the test item, the animals were observed for 14 days. General and detailed clinical observations were conducted daily during the entire experiment. Body weights of the animals were determined on days 0, 7, and 14. All the animals survived the experiment and were euthanized after the observation period. Gross examinations did not reveal any pathological changes in the examined animals. On the basis of these results, the test substance is not classified according to the CLP Regulation (EC) no 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch score = 1. GLP study.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route: Key study: The acute oral toxicity study on rats was performed according to the OECD Guideline 420 and EU Method B.1. bis, (GLP study). On the grounds of the preliminary experiment results, four animals used in the main experiment were given the test item at a dose of 2000 mg/kg b.w. The test item in the form of an oil suspension was administered with a metal stomach tube. After the administration of the test item, the animals were observed for clinical observations and body weight determinations during 14 days. The animals survived the experiment. After the 14-day observation period, the animals were euthanized and subjected a detailed gross examination. Gross examinations did not reveal any pathological changes in the examined animals.
On the basis of these results, the test substance is not classified according to the CLP Regulation (EC) no 1272/2008.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for classification or non-classification
The test substance is not classified for acute toxicity according to CLP Regulation (EC) no 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.